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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name microscope, specular
510(k) Number K120264
Device Name KONAN SPECULAR MICROSCOPE XIV
Original Applicant
KONAN MEDICAL, INC.
2976 calle gaucho
san clemente,  CA  92673
Original Contact david s fernquist
Regulation Number886.1850
Classification Product Code
NQE  
Date Received01/30/2012
Decision Date 04/11/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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